Global Pharma Briefs: News from AstraZeneca, Gilead Sciences, Biogen

By Miranda Greenberg -

January 7, 2021

A roundup of news from Canada (Bausch Health), China (Shanghai Pharma), Germany (Biogen), Italy (Angelini), the UK (AstraZeneca), and the US (Gilead Sciences and others).

Canada

Bausch Health To Reduce Debt By $275 M
Bausch Health Companies (formerly Valeant Pharmaceuticals) has paid down an additional $275 million of its senior secured term loans on December 31, 2020 using cash on hand and cash generated from operations.

Following this repayment, the company will have no debt maturities or mandatory amortization payments until 2024. Bausch Health's total debt repayment in the fourth quarter of 2020 will be approximately $480 million. For the full year of 2020, the company will repay a total of approximately $900 million of debt from cash on hand and cash generated from operations.

Source: Bausch Health


China

Shanghai Pharmaceuticals Plans $1.2-Bn Investment in Biomedical Complex
Shanghai Pharmaceuticals Holdings, a Shanghai, China-based pharmaceutical group, has announced plans to invest 8 billion yuan ($1.2 billion) for the construction of a new biomedical industrial park in Pudong New Area, Shanghai, China.

The company plans to create a national biomedical innovation industry cluster that provides innovation-incubation-services and industrialization platforms focused on therapeutic antibodies, cell therapies, gene therapies, and other biomedical areas. The complex will be constructed in phases. The total investment of the project is initially estimated to reach 8 billion yuan ($1.2 billion).

Source: Shanghai Pharmaceuticals


Germany

Biogen, ViGeneron in Gene-Therapy Pact
Biogen and ViGeneron, a Starnberg, Germany-based gene-therapy company, have entered into an agreement to develop and commercialize gene-therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases.

The companies will use ViGeneron’s proprietary vgAAV, engineered AAV capsids, to transduce retinal cells via intravitreal injections. ViGeneron will optimize and validate in vitro therapeutic candidates for an undisclosed target to treat inherited eye disease. Biogen has the right to add an additional reserved target within two years after the effective date. The companies will work together on the in vivo proof of concept. Biogen will be responsible for all further development and commercialization of the selected therapeutic candidates.

ViGeneron will receive an undisclosed upfront payment and R&D funding from Biogen. In addition, ViGeneron will be eligible to receive development, regulatory and commercial milestone payments, and will also be eligible to receive tiered royalties on net commercial sales of products arising from the collaboration.

Source: ViGeneron


Italy

Angelini Pharma To Acquire Arvelle Therapeutics for $960 M
Angelini Pharma, a Rome, Italy-based pharmaceutical company and part of the Angelini Group, has agreed to acquire Arvelle Therapeutics, a Basel, Switzerland-based biopharmaceutical company focused on treatments for central nervous system disorders, in a $960-million deal.

Arvelle was founded in 2019, and its lead product is cenobamate, an antiseizure medicines for treating drug-resistant focal-onset seizures in adults. The product is approved in the US, and the company is working with the European regulators to advance its marketing authorization application and has prepared for launch by building an organization throughout Europe.

Under the agreement, Angelini will acquire Arvelle in an all cash transaction for a total aggregate valuation of up to $960 million. Following regulatory approval, $610 million will be paid. Subsequently, and subject to cenobamate reaching certain revenue targets, a further $350 million will be paid.

Following Angelini’s acquisition of Arvelle, Angelini will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the UK). Angelini plans to launch cenobamate after receiving approval from the European Medicines Agency, which is expected in 2021.

SK Biopharmaceuticals, a pharmaceutical company based in Gyeonggi, South Korea, has agreed to sell its 12% stake in Arvelle to Angelini Pharma. SK Biopharmaceuticals will remain eligible to receive all payments inherited by the license agreement signed between Arvelle and SK Biopharmaceuticals in February 2019. In addition, revenue share payments due to certain of the Arvelle shareholders will be assumed by Angelini Pharma.

Source Angelini Pharma and Arvelle Therapeutics


UK

AstraZeneca Divests Hypertensive Drugs to Cheplapharm
AstraZeneca has completed the divestment of its commercial rights in over 70 countries of its anti-hypertension drugs, Atacand (candesartan cilexetil) and Atacand Plus (a fixed-dose combination of candesartan cilexetil and hydrochlorothiazide), to Cheplapharm Arzneimittel GmbH, a Greifswald, Germany-based supplier of branded products.

Under the agreement, AstraZeneca received a payment of $250 million from Cheplapharm, and will receive further non-contingent payments equal to $150 million during the first half of 2021.

In 2019, Atacand and Atacand Plus generated sales of $148 million and profit before tax of $89 million in the countries covered by the agreement.

Source: AstraZeneca


US

Nostrum Issues Another Voluntary Recall of Metformin ER Tablets
Nostrum Laboratories, a Kansas City, Missouri-based manufacturer, marketer, and distributor of pharmaceutical products, is voluntarily recalling one lot of metformin hydrochloride extended-release (ER) tablets (USP 750 mg) to the consumer level in the US due to exceeding acceptable daily intake limit levels of a nitrosamine impurity, N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Metformin ER is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.

This is an additional recall for the company for NDMA impurities in its metformin-ER products. In November 2020, Nostrum voluntarily recalled two lots of metformin-ER tablets (USP 750 mg) in the US due to exceeding acceptable daily intake limit levels of NDMA.

These recalls are the latest in a series of recalls for NDMA impurities in metformin-ER products and of NDMA impurities in other products. In June 2020, five companies—Teva Pharmaceuticals USA, Lupin, Apotex, Anmeal Pharmaceuticals and Marksans Pharma—voluntarily recalled in the US select lots of metformin ER formulations due to elevated levels of NDMA. In September 2020, Sun Pharma recalled one lot in the US of Riomet ER (metformin hydrochloride for ER oral suspension), 500 mg per 5 mL, to the consumer level. In October 2020, Marksans made an additional recall of 76 lots of metformin hydrochloride ER tablets (USP 500 mg and 750 mg) to the consumer level.

These recalls are part of an ongoing investigation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) into nitrosamine impurities in certain active pharmaceutical ingredients (APIs) with metformin extended-release products being the latest product of inquiry. In 2018, the FDA and the EMA initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach.

Source: US Food and Drug Administration


Gilead’s Kite, Oxford BioTherapeutics Form Cell-Therapy Research Pact
Kite, part of Gilead Sciences, and Oxford BioTherapeutics, an Oxford, UK-based clinical-stage biopharmaceutical company focused on immuno-oncology and antibody-drug conjugate (ADC)-based therapies, have entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor indications.

Under the collaboration, Oxford BioTherapeutics will validate five novel oncology drug targets, previously identified using its OGAP discovery platform, and generate antibodies against these targets. Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.

Under the agreement, Oxford BioTherapeutics will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain discovery, clinical and regulatory milestones, as well as royalties on future potential sales.

Source: Kite and Oxford BioTherapeutics


Taysha Gene Therapies To Invest $76 M in Gene-Therapy Mfg Facility
Taysha Gene Therapies, a Dallas, Texas-based company developing adeno-associated viruses (AAV)-based gene therapies, has agreed to acquire a manufacturing facility with a $75-million investment.

The company has entered into a lease agreement to occupy and configure an approximately 187,000-square-foot commercial-scale cGMP manufacturing facility in Durham, North Carolina for preclinical, clinical, and commercial production of its gene therapy pipeline. The company will invest $75 million and create approximately 200 jobs over a two-and-a-half-year period to build out development, analytical, manufacturing and quality control testing capability.

Multiple production suites, with total capacity of 2,000 liters, are expected to be fully commissioned by 2023. The addition of this internal capacity will add to the company’s capacity from its existing manufacturing collaborations with The University of Texas’ Southwestern’s Gene Therapy Program and Catalent.

Taysha is developing gene therapies to treat monogenic diseases of the central nervous system in both rare and large patient populations. The investment is part of manufacturing strategy to meet supply demands of multiple concurrent clinical programs emerging from its gene therapy pipeline as the company anticipates having four open Investigational new drug applications in 2021.

Source: Taysha Gene Therapies


Oncorus To Build Immunotherapy Mfg Facility
Oncorus, a Cambridge, Massachusetts-based clinical stage biopharmaceutical company developing viral immunotherapies, has signed a 15-year lease to build an 88,000-square foot viral immunotherapy clinical manufacturing facility in Andover, Massachusetts.

The facility is intended to support Oncorus’ chemistry, manufacturing and controls development needs for the supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.

Oncorus is advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple cancer indications based on its oncolytic herpes simplex virus (oHSV) platform and synthetic virus platform. The company is currently conducting a Phase I clinical trial of its lead product candidate, ONCR-177, an immunotherapy being developed for multiple solid tumor indications. The company anticipates reporting interim data from this Phase I trial in the second half of 2021 through the second half of 2022.

Oncorus says it plans to nominate its first intravenously administered synthetic virus clinical candidates in the first half of 2021 and its second intratumorally administered oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, a malignant tumor affecting the brain or spine, in the second half of 2021.

Source: Oncorus


Lantern Pharma, Califa Pharma in Pact To Launch ADC Program
Lantern Pharma, a Dallas, Texas-based clinical-stage biopharmaceutical company developing precision therapeutics in oncology, has entered into an agreement with Califa Pharma, a La Jolla, California-based pharmaceutical company, to launch the development of its antibody drug conjugate (ADC) program.

Lantern says it will potentially use the patent-protected linker library, conjugation processes and payloads, including its own DNA damage causing compounds, LP-100 and LP-184, for development of ADC-based therapies for a range of solid tumors and blood cancers. In addition, Lantern says it intends to use its artificial intelligence (AI) platform, known as RADR, to help determine the cancer types, targets, and cancer biomarker signatures believed most likely to respond to and benefit from this ADC approach.

The ADC program will begin immediately (as reported on January 4, 2021) and initially focus on evaluating Califia’s patented linker technologies with DNA-damaging small molecules, LP-100 and LP-184, in select solid tumors. Lantern also expects to use RADR to guide the selection and prioritization of certain tumors and cancer subtypes and also to uncover cancer sub-types, especially in rare tumors and orphan indications.

The company says the ADC development program will be optimizing target indications and design during 2021, with the intent to launch investigational new drug (IND) and clinical programs in 2022. Subject to positive results of the evaluation and early development process, Lantern expects to further a license(s) that cover the intended targets, payloads and linkers to be brought into the clinical development process.

Source: Lantern Pharma


Aprecia, Battelle Enter 3D-Printing Pharma Mfg Partnership
Aprecia Pharmaceuticals, a Blue Ash, Ohio-headquartered specialty pharmaceutical company with a three-dimensionally-printed (3DP) platform, and Battelle, a Columbus, Ohio-based research and development organization, have entered into an agreement to accelerate and expand advanced services in 3DP pharmaceutical manufacturing. The collaboration will be focused on advancing 3DP equipment from clinical supply through commercial scale while increasing manufacturing throughput and efficiency at.

Source: Aprecia